Kornimate/medical-research-clean huggingface dataset:
sedation and pain (the effect of iv sedation on pain perception)

Conditions: Pain

Summary: the investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fmri(objective).

we propose to contrast and compare the effect of propofol and midazolam, two gaba-related sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in human volunteers by asking a participant to rate their pain and by evaluating a subject's brain activation using fmri.

Eligibility criteria:
inclusion criteria: healthy subjects * 19 years or older able to follow study instructions exclusion criteria: * age less than 19 or greater than 40 * pregnant female * obesity (bmi \> or =35) * non-english speaking/reading participants * sleep apnea * pulmonary problems such as moderate or severe bronchial asthma * cardiovascular problems such as hypertension * history of claustrophobia * presence of a pacemaker, defibrillator, surgically placed metallic object (e.g., hip replacement)or other implanted device * presence of an unremoved bullet or shrapnel in the body * presence of a prosthetic that is not removable * presence of a hearing aid needed for hearing * head girth exceeding that of the head coil used in the magnet * extensive metalwork on or in teeth, or irremovable false teeth or bridgework * epilepsy * chronic analgesic medication * excessive tattoos (due to local skin heating with tattoos containing ferromagnetic particles) * history of surgery for which details are unavailable * allery due to study drugs * history of drug abuse

Keywords: pain propofol dexmedetomidine midazolam effects of sedation on pain perception.
heaven criteria vs modified lemon score for predicting difficult intubation

Conditions: Intubation; Difficult or Failed; Intubation Complication

Summary: emergency tracheal intubation is a lifesaving procedure frequently performed on critically ill and injured patients in the emergency department (ed). emergency intubations are more difficult than elective intubations in the operating room setting because of the sicker patient population with a limited physiologic reserve and less controlled setting in the ed. indeed, the proportion of difficult intubation ranges from 10% to 27% in the ed setting , whereas the rate ranges from 1% to 9% of elective intubation in the anaesthesia setting. because emerging evidence demonstrates that repeated intubation attempts are associated with an increased risk of adverse events, early recognition of difficulty intubation with a systematic use of rescue methods in ed patients is critical. the commonest airway prediction tool is the lemon score. in the modified lemon score "mallampati" was excluded as it was not a pragmatic assessment in the ed. existing difficult airway prediction tools were derived in the elective surgery environment and may not be applicable to emergency airway management. lemon criteria was designed for preoperative clinical setting. hence in this study we are observing if heaven (h- hypoxemia e - extremes of age a - anatomical abnormalities v - vomit/ blood / fluid e - exsanguination/anaemia n - neck mobility issues) is a better tool for predicting difficult intubatio.


Eligibility criteria:
inclusion criteria: * 1. all patients who undergo an endotracheal intubation in the emergency medicine department and 2. who legally give consent for the study or relatives give consent exclusion criteria: * patients not consenting for the study or · patients in cardio respiratory arrest

Keywords: heaven criteria modified lemon difficult airway prediction tool
rct comparing emdr and cbt for treatment of resistant depression

Conditions: Eye Movement Desensitization and Reprocessing; Cognitive Behavioral Therapy; Neurobiological Processing; Depression; Functional Magnetic Resonance Imaging; High Definition Electroencefalography; Heart Rate Variability

Summary: depression is one of the most common invalidating mental disorders, ranked by world health organization as the single largest contributor to global disability. current recommended treatments for depression include antidepressant medication and according to guidelines, cognitive behavioral therapy (cbt) and interpersonal therapy (ipt). despite encouraging preliminary results (e.g., matthijssen et al., 2020), eye movement desensitization and reprocessing (emdr) therapy is not yet recognized as an effective therapy for depression by apa and nice. the project aims to conduct a large multisite study that addresses the shortcomings of previous efficacy research on emdr for depression. the primary aim is to evaluate the effectiveness of emdr therapy in reducing depressive symptoms in adults with major depression as compared to cbt. secondary aims of the study are the effectiveness of emdr, as compared to cbt and tau, in improving anxiety, and other symptoms. it is hypothesized that emdr is not inferior to cbt.

the study is a multicenter clinical randomized controlled trial, conducted in italy, usa and uk that will assess the effectiveness of emdr therapy compared to cbt and tau. patients will be recruited at four clinical centers: turin and rome in italy, and kansas city in usa. the study protocol was approved by the local research ethics committee in each of the countries where the intervention is implemented.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of major depressive disorder, single episode or recurrent, according to the diagnostic and statistical manual of mental disorders (dsm-5); 2. a score of at least 20 on beck's depression inventory-ii (bdi-ii); 3. having received adm treatment with a stable dose for at least six weeks and maintained stable during treatment; 4. legal capacity to consent to the treatment. exclusion criteria: 1. diagnosis of current ptsd (assessed with mini-plus and the international trauma questionnaire - itq, cloitre et al., 2018); 2. diagnosis of complex ptsd (assessed with the itq); 3. history of psychotic symptoms or schizophrenia; 4. bipolar disorder or dementia; 5. cluster a and b severe personality disorders; 6. dissociative symptoms (des-b score \>2); 7. any substance-related abuse or dependence disorder (except those involving nicotine) in the 6 months prior to the study; 8. a serious, unstable medical condition; 9. a severely unstable social and economic condition (e.g. no fixed abode; job loss without any other source of income); 10. being pregnant; 11. acute suicidality that needs hospitalization

Keywords: depression neurobiology of emotions cognitive behavioral therapy eye movement desensitization and reprocessing trauma psychotherapy
clinical effects of pacifier use in preterm during orogastric tube feeding: randomized controlled trial

Conditions: Premature; Pacifiers; Tube Feeding; Neonatal Nursing

Summary: the purpose of the study was to assess how preterm babies' vital signs, feeding time, and gastric residual volume were affected by using a pacifier only or a pacifier with breast milk during orogastric tube feeding.


Eligibility criteria:
inclusion criteria: * feeding with the orogastric tube * breastmilk along with formula (babies who receive more than 50% of their total feed in 24 hours from formula) * gestation week between 29+0 weeks and 34+0 weeks * weight of 1000 g or more exclusion criteria: * receiving mechanical ventilator support * development of sepsis * presence of neurological disease * presence of chromosomal or congenital anomalies * presence of intraventricular bleeding * unstable physiological parameters * no breast milk
a comparative study between lysine clonixinate+cyclobenzaprine and caffeine+carisoprodol+sodium diclofenac+paracetamol

Conditions: Low Back Pain

Summary: non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using analogue visual scale (avs) for pain evaluation. secondary endpoint: to evaluate the products safety at the gastrointestinal system.

phase iiib, non-inferiority, multicentric, double-blind study.population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction, aged 18 (eighteen) and 65 (sixty five) years, without previous history of stomach or duodenal ulcer and gastritis.

Eligibility criteria:
inclusion criteria: * informed of the nature of the study and given written informed consent * patients with mild to moderate lumbago * aged between 18 and 65 years old exclusion criteria: * known allergy or sensitivity to drug components * treatment with another anti inflammatory or corticoid * treatment with oral anticoagulants * treatment with oxidase monoamine 2 weeks before the study * treatment with methotrexate * stomach or duodenal ulcer and gastritis * dehydration * acute myocardial infarction or heart failure * hyperthyroidism * pregnant or lactating patients * treatment with lithium * user of alcohol and barbiturates * hepatic or renal failure

Keywords: clonixin anti-inflammatory agents, non-steroidal cyclooxygenase inhibitors lysine l-lysine lysine acetate lysine hydrochloride amitriptyline
breast cancer in pregnancy register study

Conditions: Breast Cancer

Summary: women who were diagnosed with breast cancer during their pregnancy may be registered in this trial. data is collected on the foetal outcome 4 weeks after delivery, maternal outcome of pregnancy as well as the breast cancer therapy applied (treatment, response to chemotherapy, type of surgery), diagnostic procedures applied (palpation, us, mammogram) and the outcome of mother and child after 5 years of therapy.

breast cancer is the most common cancer malignancy in women of childbearing age after the age of 25 years. since the incidence of breast cancer under the age of 40 is increasing, and women tend to delay pregnancy into later reproductive years, the coincidence of pregnancy and breast cancer is increasing. about 1 in 1,000 pregnancies is complicated by breast cancer. nevertheless, little is known about the right therapy for the mother and the unborn child. we are therefore carrying out a trial, collecting prospective and retrospective data about pregnant women, with histological confirmed breast cancer. data on the biology of the tumour and placenta tissues is also collected. the anonymous data is collected in a database.

Eligibility criteria:
inclusion criteria: * cohort 1: women with histologically confirmed breast cancer during pregnancy * cohort 2: patients ≤ 40 years with histological confirmed breast cancer who are not pregnant (patients who have been pregnant recently can also be collected into this cohort) * informed consent for data collection (for prospective participants) and biomaterial collection. for retrospective participants an informed consent is not required as long as the data are anonymously captured exclusion criteria: * cohort 1: diagnosis of breast cancer outside the period of pregnancy * cohort 2: age at diagnosis of breast cancer \> 40 years

Keywords: breast cancer in pregnancy prospective and retrospective register study
comparison of home exercises and home exercise pogram taught by physiotherapist in women with gestational diabetes

Conditions: Gestational Diabetes

Summary: participants will be randomized and divided into 3 groups. the exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. they do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. in the second group, the same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. in the 3rd group, the participants will not be given any exercise program, they will be asked to continue their routine care.

45 pregnant women who applied to çamlıca medipol hospital gynecology and obstetrics and were diagnosed with gestational diabetes will be included in the study. being between the ages of 20-40, pregnancy of 26-30 weeks, being diagnosed with gestational diabetes as a result of oral glucose tolerance test, bmi\>45 kg/m2, being physically inactive are inclusion criteria. exclusion criteria are being younger than 18 years of age, having a history of type 1 or type 2 diabetes, having undergone bariatric surgery, using drugs that cause weight gain, and contraindications that prevent exercise. participants will be randomized and divided into 3 groups. the exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. they do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. in the second group, the same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. in the 3rd group, the participants will not be given any exercise program, they will be asked to continue their routine care. participants' fasting glucose and hba1c values, anthropometric measurements, physical activity levels with the "pregnancy physical activity questionnaire (gfaa) and their quality of life with the world health organization quality of life scale short form will be evaluated.

Eligibility criteria:
inclusion criteria: * being between 20-40 years old * 26-30. week of pregnancy * diagnosis of gestational diabetes as a result of an oral glucose tolerance test * bmi\>45 kg/m2 * being physically inactive exclusion criteria: * being under the age of 18 * history of type 1 or type 2 diabetes * have had bariatric surgery * use of drugs that cause weight gain * contraindications preventing exercise

Keywords: gestational diabetes home exercise physiotherapist
melatonin as a circadian clock regulator, neuromodulator and myelo-protector in adjuvant breast cancer chemotherapy

Conditions: Sleep Disorders, Circadian Rhythm; Depression; Genotoxicity; Pain

Summary: breast cancer is the second most common cancer in the world, the most common in women, representing the leading cause of death in brazil. the therapeutic approach for breast cancer includes surgery, radiotherapy, chemotherapy and endocrine therapy. chemotherapy courses with side effects because the cytotoxic effects affect indistinctly neoplastic cells and normal cells. the cancer per se may promote disruption in circadian rhythm. chemotherapy induces or enhances desynchronization of the sleep-wake cycle, which competes with impaired memory, mood, pain and poor quality of life. melatonin is an attractive therapeutic option in this context. this neurohormone also has immunomodulatory, co-analgesic and anti-depressant properties. additionally, the antioxidant properties of melatonin may decrease free radical formation, reducing damage to dna. the objective is to assess the response to melatonin as a synchronizer of the sleep-wake rhythm, neuromodulator, and mieloprotetor genoprotetor in the effects induced by chemotherapy in women with breast cancer.

this is a randomized, double-blind clinical trial, parallel, placebo-controlled trial. breast cancer women treated surgically and with indication for adjuvant chemotherapy, aged between 18 and 75 years will be included. patients will be randomized to receive 20mg of melatonin or placebo at bedtime. treatment will initiate seven days before the start of chemotherapy to three days after the first cycle, totaling ten days. the sleep-wake rhythm will be assessed by actigraphy, which use will precede three days to start treatment. we will also evaluate the sleep-wake cycle by sleep diary. other parameters will be measured as depressive symptoms, pain threshold pressure, effect on platelets and white series, the pain response to conditioned stimuli and quality of life. serum markers of neuroplasticity will be measured as the derivate nerve factor brain bdnf and s100 β. the icronucleus effect will quantified by cell material from the oral mucosa. we expect that the use of melatonin, as a competitor to chemotherapy and synchronizer, improves tolerance to adjuvant treatment of breast cancer chemotherapy adverse effects.

Eligibility criteria:
inclusion criteria: * female * diagnosed with breast cancer * indicated for the adjuvant treatment for breast cancer * between 18 years and 75 years * alphabetized exclusion criteria: * undergone chemotherapy or radiotherapy before inclusion in the study. * pregnant * epilepsy * brain stroke * multiple sclerosis * bmi above 45 kg / m 2

Keywords: melatonin breast cancer chemotherapy sleep-wake rhytms circadian rhythms
study of human central nervous system stem cells (hucns-sc) in patients with thoracic spinal cord injury

Conditions: Thoracic Spinal Cord Injury; Spinal Cord Injury; Spinal Cord Injury Thoracic; Spinal Cord Trauma

Summary: this study will evaluate the effect of single transplantation of hucns-sc cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.

study subjects will receive immunosuppression for nine months following transplantation. all enrolled subjects will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years.

Eligibility criteria:
inclusion criteria: * t2-t11 thoracic spinal cord injury based on american spinal injury association (asia) level determination by the principal investigator (pi) * t2-t11 thoracic spinal cord injury as assessed by magnetic resonance imaging (mri) and/or computerized tomography (ct) * asia impairment scale (ais) grade a, b, or c * minimum of six weeks post injury for the initiation of screening * must have evidence of preserved conus function * must be at stable stage of medical recovery after injury exclusion criteria: * history of traumatic brain injury without recovery * penetrating spinal cord injury * evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma * previous organ, tissue or bone marrow transplantation * previous participation in any gene transfer or cell transplant trial * current or prior malignancy

Keywords: thoracic spinal cord injury spinal cord injury thoracic sub-acute spinal cord injury human neural stem cells stem cells stem cells transplant stem cells transplant spinal cord injury
chemoembolization for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the aim of the current study is to study the safety and effectiveness of tace using a high dose of cisplatin for treatment of hcc. it is hypothesized that the formulation is safe and it improves the therapeutic effect of conventional tace.

most patients with hcc are diagnosed at an intermediate and advanced stage when the tumors become unresectable, transcatheter arterial chemoembolisation (tace) has been widely accepted as a standard treatment for them in most international management protocols. the therapeutic effect of tace in terms of objective tumor response is variable and modest (27%-40%), indicating that there is actually much room for improvement in the treatment. internationally, high doses and combination of chemotherapeutic agents are being routinely and widely used for tace in major medical centers. locally, a low dose of cisplatin (10mg) has been used as the chemotherapeutic agent for tace in hong kong. there is evidence showing that the component of chemotherapeutic agent in tace does play a significant role in the treatment effect of tace. in an attempt to improve the treatment effect of tace, the investigators propose a formulation of tace using a high dose of cisplatin as chemotherapeutic agent.

Eligibility criteria:
inclusion criteria: patient factor 1. age \> 18 2. child-pugh a or b cirrhosis 3. ecog performance status grade 2 or below 4. no serious concurrent medical illness 5. no prior treatment for hcc except for liver resection 6. creatinine clearance \>55ml/min. tumor factor 1. hcc diagnosed by typical enhancement patterns on cross sectional imaging or histology. 2. unresectable and locally advanced disease without extra-hepatic disease 3. massive expansive tumor type with measurable lesion on ct 4. total tumor mass \< 50% liver volume 5. largest tumor of greatest dimension ≤ 15cm exclusion criteria: patient factor 1. serum creatinine level \> 130 umol/l 2. presence of biliary obstruction not amenable to percutaneous drainage 3. child-pugh c cirrhosis evidence of impaired liver function 1. history of hepatic encephalopathy, or 2. intractable ascites not controllable by medical therapy, or 3. history of variceal bleeding within last 3 months, or 4. serum total bilirubin level \> 40 umol/l, or 5. serum albumin level \< 30g/l, or 6. inr \> 1.3 tumor factor 1. presence of extrahepatic metastasis 2. infiltrative lesion 3. diffuse lesion vascular complications 1. hepatic artery thrombosis, or 2. partial or complete thrombosis of the main portal vein, or 3. tumor invasion of portal branch of contralateral lobe, or 4. hepatic vein tumor thrombus, or 5. significant arterioportal shunt, or 6. significant arteriovenous shunt
evaluate the utility of the prolung china test in the diagnosis of lung cancer

Conditions: Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Summary: a study to evaluate the utility of the prolung china test as an adjunct to ct scan in the diagnosis of lung cancer.

this study will assess the stability of the prolung china test classification algorithm when used as an adjunct to ct scan. this study will assess whether there are any potential safety concerns of the prolung china test when used to evaluate patients with a positive ct scan for lung cancer.

Eligibility criteria:
inclusion criteria: 1. subject is male or female, age 18 to 80. 2. subject has undergone ct scan of the lung(s) that indicates one or more nodules or lesions. 3. subject's pulmonary nodule or lesion is greater than 4mm and smaller than 50mm. size is determined by the largest nodule or lesion dimension identified from ct imaging. 4. subject must be able to receive a prolung china test within 30 days of abnormal ct within 14 days prior to the tissue biopsy or surgical resection. exclusion criteria: 1. subject has an implanted electronic device in the chest. subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis. 2. subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules. 3. subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the prolung china test or within the previous 14 days for a bronchoscopic procedure. 4. subject presents with an anomalous physical or anatomical condition that precludes prolung china test measurement. 5. subject will have undergone unusually strenuous exercise within 24 hours. 6. subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the principal investigator would make him/her unsuitable for the study.